Turing raised the price of Daraprim, the only drug available to treat toxoplasmosis, from $13.50 a pill to $750 a pill after acquiring it in August 2015. After a firestorm of criticism, the company then reduced its price to $375 -- though critics noted that the new price was still a 2,500% increase over the initial cost.

Sen. Susan Collins (R-Maine), chair of the committee, said that it had collected more than 1,000 pages of documents including emails, PowerPoints, and Skype conversations, to examine Turing's business dealings and those of another firm, Retrophin, with a similar business model. Both firms were formerly run by investor Martin Shkreli, currently being prosecuted for securities fraud unrelated to the alleged price-gouging.

The implantable device monitors for ST-segment changes on intracardiac electrocardiogram. When detected, the internal device (similar in size and placement to a pacemaker) vibrates to alert the patient while also setting off an external alert device. According to the sponsor's briefing document, "The Guardian System is designed to reduce the time from a coronary occlusion until presentation at a medical facility."

In the ALERTS study, AngelMed met its safety endpoint -- freedom from device-related complications at 6 months -- but failed to show efficacy in prevention of late hospital arrival (>2 hours), new Q-wave, and death. In addition, the study was terminated prematurely due to concerns of unreliable data -- a major protocol violation in the eyes of the FDA reviewers.

No Change for Doc Pay: MedPac

One of the most interesting things about the Medicare Payment Advisory Commission's (MedPAC) most recent report to Congress is what it didn't say -- it didn't suggest increasing physician reimbursement under Medicare.

"The evidence suggests that payments for physicians and other health professionals are adequate," wrote the authors of the report, which was released Tuesday. "Therefore, the commission recommends the [update suggested under] current law for 2017."

What's interesting about that recommendation "is in years past, there has been an assessment by MedPAC that primary care physicians aren't paid properly -- that there are problems with the fee schedule and there's a negative affect on primary care physicians," said Ann Hollenbeck, JD, of the Honigman law firm in Detroit, in a phone interview. "They're not raising that same concern again, which has been a real and perceived concern for many years. That surprises me."

Califf: FDA Workforce Needs Strengthening

The nation's new FDA commissioner called enhancing the agency's workforce and curbing the opioid epidemic key goals.

Fifteen years ago the path to developing a drug was "lengthy" and "prolonged" from finding the right target, to developing a specific approach, to influencing that target, Califf explained.

The scientific and technological landscape has changed dramatically in that time. Moreover, many new treatments work best in concert with other drugs and require diagnostic testing, all of which affect the FDA's approach to regulating new drug and device applications.

Next Week

The Senate is on recess for 2 weeks.

Fox News canceled Monday's debate after Donald Trump and Gov. John Kasich pulled out of the event.

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